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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

European Commission to Evaluate EMA’s Fee System

Late next year, the European Commission will begin reviewing the pharmaceutical company fee system that helps fund the European Medicines Agency (EMA).

“The effectiveness and the efficiency of the system will be examined notably with respect to the sustainability and the fairness of the financial model of the fees charged by EMA to industry at large, including the remuneration paid by EMA to rapporteurs and experts from national competent authorities,” the commission said in an evaluation roadmap posted online Tuesday.

Background

The EMA can authorize new drugs under the centralized procedure for all of the EU member states, and provide scientific help to member state competent authorities if there’s disagreement authorizing new medicines under the decentralized procedure (authorization of a new medicine in several member states in parallel) or the mutual recognition procedure (a medicine is authorized in several member states based on an existing authorization in a member state). EMA also provides technical and administrative support to a coordination group composed of the member states' authorities.

In order to fulfill these obligations, EMA charges pharmaceutical companies fees to assess their applications for a marketing authorization under the centralized procedure, and for changes made to marketing authorizations, as well as annual fees for authorized medicines. Pharmacovigilance activities are also financed via fees.

Review

This evaluation, expected to begin in Q3 of 2016 and end in Q4 of 2017, is linked to the general fee regulation of EMA, which originally called for the evaluation to occur by 24 November 2010.

But the commission says the report “has not been presented to date, due to adoption of the pharmacovigilance fee regulation of EMA, which set up new fees specifically for the pharmacovigilance activities of EMA,” and also stipulated that any future revisions of the fees levied by the agency should be part of a “transparent and independent evaluation of the costs of the agency and the costs of the tasks carried out by the national competent authorities.”

EMA and national competent authority consultations will be conducted in the first quarter of 2017 in order to understand more about the agencies’ cost structures.

And then an open public consultation with industry groups, patient and provider organizations, member states and EMA will be carried out in the second half of 2017 based on the preliminary conclusions following the initial evaluation.

“Sustainability is understood mainly as to what extent the system is based on a cost-related model. The evaluation will focus on unitary costs / fees per type of procedure. In addition, some fees, notably annual fees, which cover some cross-cutting activities of the agency, such as IT activities, will also fall under the scope of the evaluation,” the commission says. “Potential for simplification and burden reduction will be explored.”

As part of the evaluation, the commission will look to “close possible data gaps of the outcome of the EMA Management Board data gathering initiative,” which assembles evidence on workload and resources, including a reflection on time spent and by whom on EU level procedures at EMA and the national competent authorities.

In addition, costing models will be proposed, discussed and applied to the time data stemming from the EMA Management Board data. These costing models will use data on cost of labour and overheads which are to be gathered from both the EMA and the national competent authorities

The evaluation will also include an analysis of the need for a dispute settlement procedure in relation to the payment of fees.